6.1 Pharmaceuticals

Main inclusion criteria

Clinical application and evaluation of pharmaceutical small molecules, therapeutic vaccines, antibodies and hormones in humans including:

• small scale settings and pilot studies
• phase I, II, III and IV trials
• assessing sensitivity, efficacy, specificity, relapse, survival, therapeutic value, pharmacokinetics, reproducibility and safety
• studies monitoring response, outcome, drug resistance and side effects

 

Advice on research activities

Includes studies of nutritional supplements used as treatments for disease.

Excludes studies focused on the potentially chemopreventative / health protective effects of specific nutrients, probiotics and nutritional supplements, which should be coded 3.3 Nutritional Prevention.
 

Official terminology

Full name of code	Short name	Unique ID
6.1 Pharmaceuticals	6.1 Pharmaceutical	HRCS_RA_6_1

 

Related external links

Common Scientific Outline (CSO) – 5.4 Systemic Therapies – Clinical Applications
 

Advice on research activities

The 3 Prevention code group should be used for primary prevention studies only and not for secondary prevention.

e.g. anti-smoking education in adolescence should be coded as 3.1 Primary prevention.

Prevention of the re-occurrence of a condition or prevention of a closely related condition arising from the pre-existing disease (secondary prevention) should not be coded within the 3 Prevention code group.

e.g. use of aspirin to prevent further adverse cardiovascular events or stroke in cardiovascular patients should be coded as 6.1 Pharmaceuticals and not 3.3 Nutrition prevention.

Prevention of a disease or condition within a specific patient group where the preventable disease is either unrelated to or may be a future sequela of the patient’s current condition can be coded as primary 3 Prevention.

e.g. prevention of cardiovascular disease in diabetic patients with no current cardiovascular disease diagnosis.

In circumstances where a study is focussed on preventing the side effects of a treatment, it would be appropriate to code to 3 Prevention and code to either 5 Treatment Development or 6 Treatment Evaluation.

e.g study of a substance preventing side effects after chemotherapy for cancer would be coded 50% 3.3 Nutrition prevention and 50% 6.1 Pharmaceuticals.

 

Main inclusion criteria

Research on chemopreventative agents and health protective effects of nutrients including

• development, characterisation and mechanism of action
• chemical contraceptives
• testing and evaluation in model systems and clinical, applied and community settings
• evaluation of evidence to inform policy

 

Advice on research activities

Includes studies focused on the potentially health protective effects of specific nutrients, probiotics and nutritional supplements plus chemopreventative studies including oral contraceptives.

Excludes general epidemiological studies of the effects of nutrition on health or association with disease.

Excludes studies where nutrients, probiotics and/or nutritional supplements are used as therapeutics treatments. Such studies should be coded as 5.1 Pharmaceuticals if in pre-clinical development or 6.1 Pharmaceuticals if in a clinical/applied setting.

Exclude studies on microbiota transplantation. These are consider cell treatments and should be coded as 5.2 Cellular and Gene Therapy for pre-clinical or 6.2 Cellular and Gene Therapy for clinical/applied.
 

Official terminology

Full name of code	Short name	Unique ID
3.3 Nutrition and chemoprevention	3.3 Nutrition	HRCS_RA_3_3

 

Related external links

Common Scientific Outline (CSO) – 3.2 Dietary Interventions to Reduce Cancer Risk and Nutritional Science in Cancer Prevention
Common Scientific Outline (CSO) – 3.3 Chemoprevention and other medical interventions
 

Main inclusion criteria

Research aimed at the primary prevention of disease, conditions or ill health, or promotion of well-being

 

Advice on research activities

This code group is for the promotion of health or primary prevention of diseases or conditions in healthy people or people without a pre-existing condition. These are frequently interventions.

Interventions aimed at individuals ‘at risk’ but who do not yet have a condition can be coded in this category

Includes policy, trial, education and evaluation studies that are aimed at health promotion or disease prevention.

Excludes secondary prevention research which will usually be covered in the 6 Treatment Evaluation or 7 Disease Management code groups.
 

Official terminology

Full name of code	Short name	Unique ID
3 Prevention of disease and conditions, and promotion of well-being	3 Prevention	HRCS_RAG_3

 

Related external links

Common Scientific Outline (CSO) – 3 Prevention
 

Summary of Prevention sub-codes